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LUNG: NSCLC; Metastatic; Adenocarcinoma; 1st line; "IMpower 150"

A Phase III, Open-Label, Randomized Study of MPDL3280A (Anti-PD-L1 Antibody) In Combination With Carboplatin + Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab In Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Title
Hoffman-La Roche GO29436
Study Title
A Phase III, Open-Label, Randomized Study of MPDL3280A (Anti-PD-L1 Antibody) In Combination With Carboplatin + Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab In Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Site Link
Malignancy
Lung Cancer, Metastatic Lung Cancer, Non-small cell lung cancer, NSCLC, Adenocarcinoma of lung
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st
Investigational Agent
Atezolizumab (MPDL3280A)
Drug Class
PD-L1 inhibitor
PI
Ari VanderWalde, MD, MPH
Sponsor
Hoffman-La Roche
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Metastatic non-squamous NSCLC
  • Treatment-naive (1st line) with following exceptions: Prior adjuvant tx at least 6 months before development of stage 4 disease; EGFR mutated cancer must have been treated with any number of anti-EGFR therapies; ALK fusions must have been treated with any number of anti-ALK therapies
  • ECOG PS 0-1
  • Previously obtained archival tissue or willingness to undergo repeat biopsy at screening
  • No active or untreated CNS malignancies. Pts with CNS involvement may only be enrolled if they have treated disease, all disease was supratentorial (no midbrain, medulla, or spine), and are off steroids.
  • No significant autoimmune disease
  • No prior immune checkpoint-inhibitor therapy

    Objective
    Primary- PFS: Secondary- ORR, OS, DoR, TTD, safety
    Assessment Frequency
    _
    Assessment Frequency 2
    _



    Assessment Frequency Link
    Path
    Adenocarcinoma, large-cell carcinoma, bronchoalveolar carcinoma
    Dosing Frequency
    q3 weeks
    Control Agents
    Bevacizuamab, Carboplatin, Paclitaxel
    Study Protocol
    Randomized
    No
    X